Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT01408576
Last Updated: 2018-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1250 participants
INTERVENTIONAL
2011-07-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Interventions
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Epratuzumab
600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
Epratuzumab
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Eligibility Criteria
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Inclusion Criteria
* Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
* Women of childbearing potential must agree to use an acceptable method of birth control
Exclusion Criteria
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
* Substance abuse or dependence
* History of malignant cancer
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
UCB Pharma
Locations
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539
Birmingham, Alabama, United States
557
Little Rock, Arkansas, United States
515
Hemet, California, United States
544
Huntington Beach, California, United States
550
La Jolla, California, United States
031
Los Angeles, California, United States
051
Los Angeles, California, United States
089
Los Angeles, California, United States
531
San Leandro, California, United States
594
Thousand Oaks, California, United States
558
Torrance, California, United States
048
Aurora, Colorado, United States
037
Colorado Springs, Colorado, United States
532
Denver, Colorado, United States
511
Bridgeport, Connecticut, United States
039
Farmington, Connecticut, United States
042
Aventura, Florida, United States
514
Brandon, Florida, United States
090
Clearwater, Florida, United States
092
DeBary, Florida, United States
533
Fort Lauderdale, Florida, United States
064
Jupiter, Florida, United States
070
Ormond Beach, Florida, United States
084
Palm Harbor, Florida, United States
518
Plantation, Florida, United States
585
Port Orange, Florida, United States
050
Tampa, Florida, United States
538
Tampa, Florida, United States
087
Vero Beach, Florida, United States
537
Atlanta, Georgia, United States
044
Duluth, Georgia, United States
590
Idaho Falls, Idaho, United States
052
Chicago, Illinois, United States
096
Indianapolis, Indiana, United States
060
Shreveport, Louisiana, United States
513
Lansing, Michigan, United States
599
Lansing, Michigan, United States
047
Saint Clair Shores, Michigan, United States
575
Florissant, Missouri, United States
549
St Louis, Missouri, United States
596
Nashua, New Hampshire, United States
568
Freehold, New Jersey, United States
593
Trenton, New Jersey, United States
067
Las Cruces, New Mexico, United States
551
Brooklyn, New York, United States
553
Great Neck, New York, United States
545
Manhasset, New York, United States
053
New York, New York, United States
577
Roslyn, New York, United States
077
Charlotte, North Carolina, United States
559
Charlotte, North Carolina, United States
058
Durham, North Carolina, United States
075
Wilmington, North Carolina, United States
061
Columbus, Ohio, United States
071
Middleburg Heights, Ohio, United States
041
Oklahoma City, Oklahoma, United States
076
Oklahoma City, Oklahoma, United States
097
Oklahoma City, Oklahoma, United States
547
Tulsa, Oklahoma, United States
032
Duncansville, Pennsylvania, United States
093
Philadelphia, Pennsylvania, United States
073
Pittsburgh, Pennsylvania, United States
094
Pittsburgh, Pennsylvania, United States
535
Charleston, South Carolina, United States
598
Myrtle Beach, South Carolina, United States
571
Jackson, Tennessee, United States
057
Memphis, Tennessee, United States
574
Amarillo, Texas, United States
078
Austin, Texas, United States
098
Austin, Texas, United States
570
Austin, Texas, United States
079
Dallas, Texas, United States
541
Houston, Texas, United States
563
Houston, Texas, United States
036
Mesquite, Texas, United States
066
San Antonio, Texas, United States
562
San Antonio, Texas, United States
534
Seattle, Washington, United States
429
Camperdown, , Australia
427
Clayton, , Australia
430
Liverpool, , Australia
425
Malvern, , Australia
426
Maroochydore, , Australia
106
Brussels, , Belgium
107
Brussels, , Belgium
105
Leuven, , Belgium
104
Liège, , Belgium
954
Belo Horizonte, , Brazil
956
Campinas, , Brazil
955
Goiânia, , Brazil
950
Juiz de Fora, , Brazil
453
Porto Alegre, , Brazil
451
Recife, , Brazil
450
Rio de Janeiro, , Brazil
952
Rio de Janeiro, , Brazil
452
Salvador, , Brazil
454
São Paulo, , Brazil
200
Sofia, , Bulgaria
202
Sofia, , Bulgaria
203
Sofia, , Bulgaria
204
Sofia, , Bulgaria
205
Sofia, , Bulgaria
500
London, Ontario, Canada
502
Hamilton, , Canada
507
Mississauga, , Canada
508
Rimouski, , Canada
506
St. John's, , Canada
504
Toronto, , Canada
218
Olomouc, , Czechia
216
Prague, , Czechia
215
Zlín, , Czechia
226
Tallinn, , Estonia
113
Lille, , France
618
Limoges, , France
617
Montpellier, , France
614
Paris, , France
116
Pessac, , France
616
Toulouse, , France
127
Berlin, , Germany
628
Berlin, , Germany
633
Berlin, , Germany
625
Cologne, , Germany
128
Frankfurt, , Germany
126
Freiburg im Breisgau, , Germany
637
Hamburg, , Germany
632
Herne, , Germany
626
Leipzig, , Germany
634
Mainz, , Germany
627
Münster, , Germany
129
Plochingen, , Germany
636
Roßlau, , Germany
631
Zerbst, , Germany
349
Shatin, , Hong Kong
712
Budapest, , Hungary
716
Budapest, , Hungary
718
Budapest, , Hungary
717
Debrecen, , Hungary
711
Szeged, , Hungary
715
Szeged, , Hungary
713
Zalaegerszeg, , Hungary
378
Ashkelon, , Israel
376
Beersheba, , Israel
375
Haifa, , Israel
377
Haifa, , Israel
381
Jerusalem, , Israel
382
Kfar Saba, , Israel
380
Rehovot, , Israel
379
Tel Aviv, , Israel
383
Tel Litwinsky, , Israel
149
Ferrara, , Italy
648
Milan, , Italy
148
Padua, , Italy
647
Pisa, , Italy
646
Roma, , Italy
147
Torino, , Italy
242
Kaunas, , Lithuania
244
Klaipėda, , Lithuania
243
Vilnius, , Lithuania
478
Guadalajara, , Mexico
976
Mexico City, , Mexico
982
Mexico City, , Mexico
480
Mérida, , Mexico
981
Torreón, , Mexico
743
Bydgoszcz, , Poland
744
Częstochowa, , Poland
752
Elblag, , Poland
754
Elblag, , Poland
746
Katowice, , Poland
748
Lublin, , Poland
750
Lublin, , Poland
742
Poznan, , Poland
747
Szczecin, , Poland
751
Ustroń, , Poland
749
Warsaw, , Poland
263
Brasov, , Romania
260
Bucharest, , Romania
262
Bucharest, , Romania
264
Bucharest, , Romania
757
Bucharest, , Romania
758
Bucharest, , Romania
261
Cluj-Napoca, , Romania
759
Constanța, , Romania
756
Galati, , Romania
761
Iași, , Romania
779
Moscow, , Russia
285
Petrozavodsk, , Russia
284
Saint Petersburg, , Russia
281
Yekaterinburg, , Russia
901
Cape Town, , South Africa
902
Durban, , South Africa
903
Stellenbosch, , South Africa
306
Busan, , South Korea
303
Daegu, , South Korea
308
Daejeon, , South Korea
301
Incheon, , South Korea
307
Seoul, , South Korea
302
Suwon, , South Korea
161
Barcelona, , Spain
661
Barcelona, , Spain
164
Bilbao, , Spain
660
Getafe, , Spain
662
Las Palmas de Gran Canaria, , Spain
162
Madrid, , Spain
163
Madrid, , Spain
664
Madrid, , Spain
166
Málaga, , Spain
165
San Cristóbal de La Laguna, , Spain
177
Santander, , Spain
663
Santiago de Compostela, , Spain
160
Seville, , Spain
659
Vigo, , Spain
325
Changhua, , Taiwan
326
Chiayi City, , Taiwan
328
Kaohsiung City, , Taiwan
330
Taipei, , Taiwan
791
Donetsk, , Ukraine
799
Ivano-Frankivsk, , Ukraine
790
Kiev, , Ukraine
794
Kiev, , Ukraine
797
Kiev, , Ukraine
792
Luhansk, , Ukraine
793
Odesa, , Ukraine
796
Vinnytsia, , Ukraine
677
Birmingham, , United Kingdom
178
Brighton, , United Kingdom
182
Doncaster, , United Kingdom
179
Leeds, , United Kingdom
181
Romford, , United Kingdom
Countries
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Other Identifiers
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2010-020859-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0012
Identifier Type: -
Identifier Source: org_study_id
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